ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
FDA 510(k) clearance K140225 · decided 2014-10-27
Clearance details
- K-number
- K140225
- Device name
- ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
- Applicant
- Phadia US, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-29
- Decision date
- 2014-10-27
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- MOB
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Freiburg Im Breisgau, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnos recall (Z-0783-2024) | Phadia Ab | 2024-01-24 |